FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FETAL MONITORING SPIRAL ELECTRODE
K Number: K905130
·
Decision Jan 29, 1991
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
16
Applicant Total
55
Review Days
75
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Basic Information
- Device Name
- FETAL MONITORING SPIRAL ELECTRODE
- K Number
- K905130
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.2675
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- Graphic Controls Corp.
- Date Received
- November 15, 1990
- Decision Date
- January 29, 1991
- Product Code
- HGP
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HGP | Electrode, Circular (Spiral), Scalp And Applicator | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HGP), ordered by most recent decision date.
Goldtrace Fetal Spiral Electrode (FSE) (CNS000004)
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FETAL SPIRAL ELECTRODE, MODEL FSE07000
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SOFT BEAT FETAL HEART RATE ELECTRODE MODEL SBT-7000
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LIFE TRACE FETAL SPIRAL ELECTRODE WITH MATERNAL REFERENCE
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CR SPIRAL ELECTRODE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
FETAL SCALP SPIRAL ELECTRODE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Other Clearances by Graphic Controls Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K981964 | MEDI-TRACE 4103 NEONATAL ELECTRODE | Nov 13, 1998 | Substantially Equivalent |
| K983287 | MEDI-TRACE 1610C COMBINATION DEFIBRILLATION, MONITORING AND PACING ELECTRODE | Nov 5, 1998 | Substantially Equivalent |
| K974730 | SOFTRANS PLUS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS PLUS IUPC) | Jul 14, 1998 | Substantially Equivalent |
| K980857 | MEDI-TRACE 1310P COMBINATION DEFIBRILLATION, MONITORING & PACING ELECTRODE | May 12, 1998 | Substantially Equivalent |
| K972970 | MEDI-TRACE 1510M COMBINATION DEFIBRILLATION, MONITORING AND PACING ELECTRODE | Aug 27, 1997 | Substantially Equivalent |
| K964387 | POINT OF USE II SHARPS-A-GATOR | Mar 27, 1997 | Substantially Equivalent |
| K964279 | SOFTRANS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 4000 SOFTRANS IUPC) | Jan 22, 1997 | Substantially Equivalent |
| K963151 | MEDI-TRACE 5700 RESTING ECG ELECTRODE | Nov 19, 1996 | Substantially Equivalent |
| K963038 | MEDI-TRACE 3600 SERIES OF ECG MONITORING ELECTRODE | Nov 15, 1996 | Substantially Equivalent |
| K960968 | MEDI-TRACE 200, MEDI-TRACE 200-30 | Oct 28, 1996 | Substantially Equivalent |